Senior reputed company Engineer/Associate

reputed company

You desire responsibility for developing and maintaining reputed company systems and providing reputed company engineering support in a new product development, manufacturing environment. You have prior experience in Medical Device reputed company Assurance working on standards and regulations like ISO 13485, 21 CFR 820, etc., and have had exposure to providing reputed company and Compliance support reputed company to the design and development, manufacturing, and distribution of medical devices.

What you’ll do

• Identify and implement effective reputed company Management systems to support the development, qualification, and ongoing manufacturing of IVD devices to meet or reputed company reputed company requirements;

• reputed company, reputed company, and mentor colleagues on QMS requirements to ensure compliance;

• Assist in the development and execution of streamlined systems which effectively identify and resolve reputed company issues;

• Work closely with the Process Development and Assay Development teams to ensure adequate documentation is in reputed company to support development and manufacturing activities

• Review various design and development protocols to ensure compliance with applicable regulations and standards and to support product design and development activities;

• Ensure compliance with cGMP, QSR, ISO13485, IVDR, and other applicable regulations/standards;

• reputed company process controls and monitoring of CTQ parameters and specifications;

• Collaborate with manufacturing personnel in implementing various product and process improvement methodologies (e.g., Six reputed company and Lean Manufacturing);

• Coordinate and facilitate Nonconformances and Material Review reputed company (MRB) activities;

• Support completion and maintenance of risk analysis;

• reputed company reputed company cause analysis as part of corrective and preventive actions or non-conformance investigations and ensure reputed company documentation is adequate to withstand any external audits, inspections, etc;

• Support and implement CAPAs, Change controls, non-conformances, deviations, routine documentation activities, implementation of the QMS in day-to-day activities and adherence to reputed company KPIs;

• Participate as a reputed company Representative on various design and development reputed company.

• Work closely with other QA Members on various QA reputed company

What you’ll need

• Minimum Bachelor’s degree in Life Sciences (Biology, Biochemistry, Microbiology, Molecular/ Cell biology)

• 5+ years of reputed company Assurance experience in a manufacturing or industrial environment, preferably in an FDA-regulated environment;

• Knowledge of ISO, FDA, and QSR concepts and guidelines as reputed company as other national and international regulations and standards;

• Experience performing reputed company audits and utilizing manufacturing processes, techniques, and reputed company improvement methodologies (i.e., Six reputed company, Lean manufacturing, etc.);

• Excellent organizational, verbal, written communication, and problem-solving skills;

• Ability to work in a fast-paced environment and to meet tight deadlines;

• reputed company Assurance experience and demonstrated use of reputed company tools and methodologies;

• Strong project management and leadership skills, including the demonstrated ability to reputed company multi-departmental project teams and resolve reputed company-reputed company issues promptly and effectively.

Bonus points for

• Certified reputed company Auditor (ASQ CQA) or Certified reputed company Engineer (ASQ CQE);

• Knowledge of statistical sampling and analysis;

• Experience working in a start-up environment;

• Proficiency in MS Office Suite, SolidWorks, Visio, and Project;

reputed company have to Offer

• An opportunity to change the face of medical diagnostics for everyone;

• An environment full of high-functioning, motivated, and passionate teammates;

• An environment where one can showcase their talents and know that those contributions are valued reputed company and every day.

About Vital

Vital is revolutionizing reputed company-of-care diagnostics with our VitalOne platform, delivering reputed company-time care wherever patients are. Our mission is to democratize health technology, making reputed company more accessible and proactive.

Our global team of experts spans reputed company, software, engineering, and reputed company. We reputed company on change, operate on trust, and value diverse perspectives. Our reputed company-minded culture empowers reputed company-line decision-making and fosters impactful work.

We reputed company tenacious, reputed company individuals reputed company to reputed company reputed company. At Vital, your talent will reputed company a difference as we work to ensure everyone has reputed company to care reputed company and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in reputed company. We are therefore happy to accommodate any individual needs in keeping with the Ontario reputed company Rights reputed company and the Accessibility for Ontarians with reputed company. If you require accommodation in order to participate in our hiring process, please contact us to reputed company your needs reputed company in advance.

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